小儿导赤片质量控制方法改进研究

目的建立小儿导赤片中大黄、栀子含量测定的高效液相色谱(HPLC)法及栀子的薄层色谱(TLC)鉴别方法。方法用TLC法和HPLC法对小儿导赤片中大黄及栀子进行定性、定量分析。结果 TLC色谱中,栀子苷和栀子对照药材斑点清晰。大黄素质量浓度的线性范围为8.096～104.48μg/mL(r=0.999 9),平均回收率为98.01%(RSD为1.25%);大黄酚质量浓度的线性范围为10.83～112.23μg/mL,r=0.999 9;芦荟大黄素的线性范围为8.12～89.90μg/mL,r=0.999 8;大黄酸的线性范围为9.96～89.48μg/mL,r=0.999 8;大黄素甲醚的线性范围为8.896～54.44μg/mL,r=0.999 7;栀子苷的线性范围为6.771～141.48μg/mL(r=1.000 0),平均回收率为99.04%(RSD为1.20)。结论定性鉴别方法专属、斑点清晰;含量测定方法可靠,重现性好。

Study on Determination of Rhubarb and Gardenia in Child Daochi Tablets by HPLC and Identification of Gardenia by TLC

Objective To establish a HPLC determination method for rhubarb and gardenia in the Child Daochi Tablets and a TLC identification method for gardenia.Methods The TLC and HPLC methods were adopted to perform the qualitative and quantitative analysis on rhubarb and gardenia in Child Daochi Tablets.Results The spots of the comparison medicinal material for gardenoside and gardenia were fairly clear by TLC identification.In HPLC quantitative analysis,the linear range of emodin was 8.096-104.48 μg/mL（r=0.999 9）,the average recovery rate was 98.01%（RSD=1.25%）;the linear range of chrysophanol was 10.83-112.23 μg/mL（r=0.999 9）;the linear range of aloe-emodin was 8.12-89.90 μg/mL（r=0.999 8）;the linear range of rhein was 9.96-89.48 μg/mL（r=0.999 8）;the linear range of physcion was 8.896-54.44 μg/mL（r=0.999 7）;the linear range of geniposide was 6.771-141.48 μg/mL（r=1.000 0）,the average recovery rate was 99.04%（RSD=1.20）.Conclusion The qualitative identification method is exclusive with clear spots;the content determination method is reliable with good reproducibility,which provides the basis for the quality control and evaluation of Child Daochi Tablets.